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The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
Sponsor: W.L.Gore & Associates
Summary
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2023-10-17
Completion Date
2032-01-31
Last Updated
2025-04-16
Healthy Volunteers
No
Interventions
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.
Locations (7)
North Suburban Medical Center
Denver, Colorado, United States
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany
Rijnstate Hospital
Arnhem, Netherlands
Auckland City Hospital
Auckland, New Zealand